Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

Skin Microbiome Clinical Trial

— Microbiome II  

Official title:

Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347927
• Other study ID #: C2753
• Status: Recruiting
• Start date: October 30, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: BSN Medical GmbH
• Contact: Hardy Schweigel, Dr.
• Phone: +49 152 2775 2954
• Email: hardy.schweigel[@]essity.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject = 18 years of age

2. Patient is physically and mentally able to participate in this study

3. Proper understanding of the Dutch language

4. Signed informed consent

5. Fractures to be treated with a short-arm cast without thumb inclusion for the period of 3 weeks (e.g. 2R3A1 = radial styloid avulsion, 2R3A2 = Simple radial fracture, 2U3A1 = Ulnar fracture of the base of the styloid process, 2U3A2= Simple distal ulna fracture, 2R3B1 = Intraarticular fracture of the styloid process of the radius (not displaced) or Triquetrum fracture (non AO classified))

Exclusion Criteria:

1. Subject <18 years of age

2. Pregnancy, breast feeding

3. Participation in other clinical trials

4. Patient is neither physically nor mentally able to participate in this study

5. Non-intact skin in treatment area (including dermatological issues)

6. Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound

7. Medical treatment prior casting which could influence the microbiome

8. Known Blood Circulatory Diseases

9. Known Lymphedema or any general disorder of the lymphatic system

10. Known Osteoporosis

11. Known Diabetes

12. Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease

13. Intolerability or documented allergies against cast materials

14. Subjects with not "normal" (unusual) hygienic behavior

15. Suspected drug addiction or alcohol abuse

16. Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects

Related Conditions & MeSH terms

• Skin Microbiome

Intervention

Device:
• water resistante padding
Delta-Dry® Softliner Tensoban® Delta-Dry®
• non water resistante padding
Delta-Net® Stockinette Delta-Rol®

Locations

Country	Name	City	State
Netherlands	Wilhelmina Ziekenhuis Assen (Assen, NL)	Assen
Netherlands	Ommelander Ziekenhuis	Groningen	Scheemda
Netherlands	Leids Universitair Medisch Centrum (Leiden, NL)	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	products´ influence on skin microbiome during fracture management	Quantity of bacteria in the skin microbiome	3 weeks
Primary	products´ influence on skin microbiome during fracture management	Taxonomic composition of skin microbiome	3 weeks
Primary	products´ influence on skin microbiome during fracture management	Alpha diversity of skin microbiome	3 weeks
Primary	products´ influence on skin microbiome during fracture management	Beta diversity skin microbiome	3 weeks
Secondary	Number of adverse events during study per product		3 weeks
Secondary	General product performance		3 weeks
Secondary	Treatment comfort		3 weeks
Secondary	Impact on daily life activities		3 weeks